BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL SIZE G RIGHT

    MDR report key: 6609910 · Received June 2, 2017

    Report

    Report Number
    3007963827-2017-00231
    Event Type
    Injury
    Date Received
    June 2, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES - NEXGEN TAPER STEM PLUG, ITEM #: 00596009900, LOT #: 63403127, NEXGEN 3 DEGREE STEMMED FLUTED TIBIAL COMPONENT SIZE 7, ITEM #: 00599805801, LOT #: 62533624, NEXGEN ALL POLY PATELLA, ITEM #: 00597206541, LOT #: 63321007, NEXGEN ARTICULAR SURFACE, ITEM #: 00596405010, LOT #: 62563710. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2017-00378 AND 0002648920-2017-00378.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT IS EXPERIENCING AN ALLERGIC REACTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389722 NEXGEN LPS-FLEX FEMORAL SIZE G RIGHT PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. 63387896

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention